Post-market clinical follow-up for continued assessment of safety and performance of the Axonics INS Model 5101 (R20). The study will include participants with the primary diagnosis of fecal incontinence who are eligible to receive the rechargeable R20 device as per the commercially available IFU.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. 18 years or older
2. Primary indication of Fecal Incontinence (FI)
3. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers
You may not be if
1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis)
2. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements
3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
